Abstract
* Many clinical trials are terminated before reaching the sample size needed to test the trials' hypotheses owing to poor recruitment.
* Registries, such as ClinicalTrials.gov, provide information on the main features of a multicenter clinical trial (MCT) to the general public.
* Site investigators are key to the success of MCTs; however, information on their recruitment performance is not publicly available.
* We propose that sponsors should disclose the recruitment targets of all site investigators on ClinicalTrials.gov before a trial starts as well as their final recruitment. Information on issues that could have affected recruitment should also be provided.
* This information will be of interest to different stakeholders such as patient organizations, sponsors, and MCT networks.
* Disclosing all site investigators' recruitment figures could prompt queries to the sponsor from the scientific community about regional subgroup analyses, to assess if ethnic or standard-of-care differences have an impact on treatment outcomes.
* Registries, such as ClinicalTrials.gov, provide information on the main features of a multicenter clinical trial (MCT) to the general public.
* Site investigators are key to the success of MCTs; however, information on their recruitment performance is not publicly available.
* We propose that sponsors should disclose the recruitment targets of all site investigators on ClinicalTrials.gov before a trial starts as well as their final recruitment. Information on issues that could have affected recruitment should also be provided.
* This information will be of interest to different stakeholders such as patient organizations, sponsors, and MCT networks.
* Disclosing all site investigators' recruitment figures could prompt queries to the sponsor from the scientific community about regional subgroup analyses, to assess if ethnic or standard-of-care differences have an impact on treatment outcomes.
Original language | English |
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Article number | e1001149 |
Pages (from-to) | - |
Number of pages | 4 |
Journal | PLoS Medicine |
Volume | 8 |
Issue number | 12 |
DOIs | |
Publication status | Published - Dec 2011 |